Introduction. Among the new antiretroviral treatment (ART) regimens, bictegravir (BIC) stands out, a recently incorporated integrase inhibitor. BIC conjugated with emtricitabine (FTC) and tenofovir alafenamide (TAF) has been shown to be non-inferior in efficacy as initiation therapy in a single daily dose regimen compared to other initiation ART. The objective of our study is to evaluate the impact of the inclusion of this new ART scheme in real clinical practice. Material and methods. Observational, retrospective and descriptive study that included all adult HIV patients (age ≥18 years) who had been treated with BIC/FTC/TAF for at least 24 consecutive weeks for 1.5 year to evaluate effectiveness, safety and economic impact. Results. A total of 115 patients were included. There were 28 patients without previous treatment, naive, (24.3%). The pretreated patients had a mean of 42±9 months of prior ART. The percentage of patients at week 24 after switching to BIC/FTC/TAF with suppressed plasma viral load was 88% in the naive group and 94.1% in the pretreated group. Adverse events were reported in 8 (7%) patients. The economic impact of the change to BIC/FTC/TAF for these patients was €1,202.63/patient/year, representing an increase of 9.3%. Conclusions. Our results correlate with the results of two phase 3 non-inferiority clinical trials in naive patients (88% and 84%) and those of a phase 3 non-inferiority clinical trial in pretreated patients (86%). However, we found a large difference between the high percentages of patients reporting an adverse event in three phase 3 clinical trials and our results.

Background Omalizumab is indicated as add-on treatment to improve asthma control in patients with severe persistent allergic asthma who have reduced lung function as well as frequent symptoms. Purpose To assess the use and efficacy of omalizumab in a regional hospital. Materials and methods We conducted a retrospective study from April 2007 to August 2013. We included all patients who were treated for at least 16 weeks with omalizumab. To evaluate use and efficacy we reviewed: baseline IgE levels, volume exhaled during the first second of a forced expiration (FEV1), use of inhaled and/or oral corticosteroids before and after treatment and disease evaluation after 16 weeks. It was considered that patients with baseline IgE lower than 76 IU/ml were less likely to experience benefit as stated in the omalizumab SPC. We defined reduced lung function as FEV1 lower than 80%. Results Total patients: 10 (9 females); mean age 52 (39–77); 9 patients with allergic asthma and 1 with chronic urticaria. There were 4 patients with moderate persistent allergic asthma and the remainder with severe asthma. Mean basal IgE 177.2 IU/mL (47–431.6). 4 patients were prescribed omalizumab with IgE lower than 76 IU/mL. The FEV1 value was only determined in 5 patients before starting treatment with omalizumab: 3 patients had FEV1 lower than 80% (49, 69 and 59), and it increased in all cases after omalizumab initiation (75, 72 and 71). 2 patients had FEV1 higher than 80% (104 and 96), which increased in the first case and decreased in the other after commencing omalizumab (117 and 78). Both had baseline IgE levels less than 76 IU/mL. After starting omalizumab all patients continued treatment with inhaled corticosteroids and 3 also with oral corticosteroids. 1 patient was completely asymptomatic, 2 had improved respiratory status, 5 were stable from a respiratory standpoint and 1 experienced non-respiratory changes with the introduction of omalizumab. Of the patients who started omalizumab with IgE levels higher than 76 IU/mL, 4 were stable from a respiratory standpoint and 1 had an improved respiratory status. We had 1 patient diagnosed with chronic urticaria with IgE 518.4 IU/mL on treatment with omalizumab 300 mg every 6 weeks (off label). The patient is currently without skin rash or need to take antihistamines. Conclusions Only 33% (3/9) patients experienced an improvement in respiratory status and 55% (5/9) were stable from a respiratory standpoint. These data are lower compared with other studies (1) reporting up to 55% effectiveness. No patients discontinued treatment with corticosteroids. Is necessary to develop a protocol to ensure that omalizumab is used in the most suitable patients and review effectiveness after starting treatment to avoid unnecessary exposure to the drug in non-responders. Omalizumab treatment for chronic urticaria has been effective. Reference Padeulles Zamora N, et al. Estudio observacional retrospectivo de la utilización de Omalizumab en el tratamiento del asma grave persistente. Farm Hosp. 2013;37(...

Background Enoxaparin is a low molecular weight heparin used in the treatment and prophylaxis of thromboembolic disease. It is metabolised in the liver and its elimination is mainly renal. Renal impairment results in a decrease in its elimination and then in a higher anticoagulant response. In patients with severe renal impairment dosage adjustment is recommended. Purpose To analyse enoxaparin dose adjustment in patients with severe renal impairment based on clinical practice guideline recommendations. Materials and methods We carried out a three-month prospective study in a 250-bed hospital. Patients treated with less than 40 mg enoxaparin were reviewed. Creatinine clearance (CrCl) <30 ml/min triggered a pharmaceutical intervention (PI), recommending 30 mg of enoxaparin for prophylaxis and 1 mg/kg/day for treatment of venous thromboembolism, unstable angina and acute non-Q wave myocardial infarction. All interventions were reported to the relevant physician through the electronic prescribing program. PIs were not performed when anticoagulation was being monitored by the haematology department. Data were obtained from the electronic prescribing (Unidosis Farmatools software application Dominion), laboratory software (GIPI) and electronic medical records (Ariadna). Results During the study, enoxaparin was prescribed to 192 patients at doses higher than 40 mg/day. 12 (6.25%) had a CrCl < 30 ml/min. PIs were performed in 83.3% (10) of these renal cases, being accepted in 80% (8). No thromboembolic events were detected during the study. PIs not accepted were due to patient discharge or recovery of renal function. Conclusions PIs improved prescribing, promoting the safe and proper use of enoxaparin, improving patient safety and reducing the risk of complications associated with overdose, with the consequent impact on the efficiency and quality of care in hospitalised patients. No conflict of interest.

sex, drug interactions and their severity, and medical action/decision. The data were obtained from the drug dispensing register of the outpatient pharmaceutical care unit and the electronic clinical record. Interactions and their severity were reviewed using www.hivdruginteractions.org/checker. Results 210 patients were reviewed, of whom 5 patients (2.38%) had interactions that motivated treatment modification, reflected in the clinical history, with a mean age of 52 years (SD 5).

Letter to the EditorCurrently, hepatitis C infection is present in 180 million people worldwide and is the main cause of end-stage liver disease and an indication for liver transplantation. 1 The different genotypes are independent of the clinical course of chronic hepatitis C but have a great impact on treatment response. New direct-acting antivirals yield a high rate of clinical response and cure. Sofosbuvir (SOF), a NS5B nucleotide inhibitor with pangenotypic activity, presents a high genetic barrier. Simeprevir (SIM), a secondgeneration NS3/A4 protease inhibitor, has activity against genotypes 1, 2, 4, 5, and 6. Also, it shows an interesting characteristic: its resistance-associated variants often disappear gradually once the treatment is stopped. 2 Currently, data on viral response in approved and experimental treatments in HCV genotype 5 (HCV-5) are scarce. Therefore, we propose to describe the first case of healing in a HCV-5 treatment-naïve cirrhotic patient treated with SIM, SOF, and ribavirin (SIM/SOF/RBV)